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Food > Meat and Poultry Products > Manual of Procedures > Chapter 11

ANNEX D-1

Risk-based Verification Sampling of Ready-to-Eat (RTE) Meat and Poultry Products
version 1.0

1. Introduction:

The following sampling plan has been designed for operators who produce ready-to-eat (RTE) products and who wish to keep their eligibility to export meat products to the United States of America.

The implementation date for this sampling plan is April 1, 2006.

2. Scope:

All establishments producing RTE meat products and that are on the eligibility list for the US must implement this risk-based sampling plan.
This sampling plan only applies to RTE meat products that are exposed in the post-lethality environment.

3. Classification of products:

The operator must indicate, for each eligible product, under which of the following alternatives it falls:

Alternative 1: Employ both a post-lethality treatment and an antimicrobial agent or process for control of Listeria monocytogenes on RTE products.
Alternative 2A: Employ a post-lethality treatment that achieves at least 1-log lethality.
Alternative 2B: Employ an antimicrobial agent or process for control of Listeria monocytogenes on RTE products that allows no more than 2-log increase through shelf life.
Alternative 3: Employ sanitation measures only.

The establishment is then classified according to the highest risk alternative product. For example, should there be products in more than one alternative, Alternative 3 has priority, followed by Alternative 2B and Alternative 2A respectively.

4. Frequency of testing

The testing frequency increases as the level of safety associated with the alternative decreases. This means that establishments under Alternative 3 need to test more frequently than establishments under Alternative 1.

Alternative	Control measure*	Risk level	Sampling frequency
Alternative 3	Sanitation only	Highest risk	12 samples per year (1 per month)
Alternative 2B	Antimicrobial agent or process (AMA/P)	Medium-high risk	6 samples per year (every other month)
Alternative 2A	Post-lethality treatment after the primary lethality process (PLT)	Medium-low risk	samples per year (1 per 4 months)
Alternative 1	AMA/P and PLT are in place	Lowest risk	1 sample per year

* Please refer to the glossary for the explanation of the different control measures.

Note:

The alternative under which the establishment falls must be validated by the Canadian Food Inspection Agency (CFIA; Inspector in charge/Program Specialist) and this information must be kept on record by the operator.
Any change in the alternative under which the establishment is classified must be documented by the operator and approved by the CFIA.

Once the testing frequency is determined, the selection of the product that will be tested must be done as per Annex A.

5. Sample collection

The operator is responsible for the sample collection process which includes the following steps:

5.1.	Training of the designated employee(s) who will work with the sampling plan in order to meet the sampling plan’s objectives/specifications.
5.2.	Collecting samples in the post-processing area of the establishment as per Annex B.
5.3.	The sample must be properly identified. This includes the name of the product, the production date or code, and the lot of production it represents (in the event that the laboratory result should be unsatisfactory).
5.4.	The sample must be kept and shipped refrigerated so its internal temperature does not exceed 7° C upon its arrival at the laboratory.
5.5.	Operators shall prepare and have a written sampling program for risk-based testing of RTE products which covers the sample collection, preparation and shipping procedures. It shall also cover means to tamper-proof and protect the integrity of samples: e.g., how samples are handled/packaged and shipped to ensure temperature maintenance and tamper proofing. The shipping procedures shall specify: who packages, where is packaging done, where are samples kept pending shipment, who ships samples; where are samples shipped (laboratory)/how are samples shipped (shipping agent) After the program has been reviewed by the CFIA V/IIC (veterinarian/inspector in charge), the establishment is required to conduct their sampling activities in accordance with their written program. The procedures shall be detailed to the extent necessary to enable CFIA V/IIC on-site verification. The general guideline for the sample collection, shipping and integrity protection is provided in Annex B.

Note:

Step 5.2: This step must be performed under direct CFIA supervision.
Step 5.3: CFIA must approve the lot as defined by the operator. Please refer to the glossary for lot definition.
Steps 5.4 - 5.5: For this purpose the V/IIC uses the appropriate inspection tasks as per MCAP tasks. In cases where the V/IIC finds that a condition is not being met, they are to document the situation and advise the Area Program Manager, Meat Program.

It is recommended to hold the production lot pending reception of the laboratory result.

6. Target Pathogens

The samples will be analysed for Listeria monocytogenes and Salmonella spp. If the product is a dry or semi-dry fermented sausage and contains beef, it will also be analysed for E. coli O157:H7.

7. Methods of analysis

For each sample, a 25-g test portion will be analysed for Listeria monocytogenes and a 325-g test portion will be analysed for Salmonella. The analysis for E. coli O157:H7, when required, will be conducted on five 65-g test portions/sample.

The following analytical methods are to be used:

Listeria monocytogenes
the FSIS MLG 8.04 and 8A.01. The Canadian method MFHPB-30.
Salmonella spp.
the FSIS MLG 4.03 and 4C.01. The Canadian methods MFHPB-20 and MFLP-29.
E. coli O157:H7 and O157:NM (Nonmotile)
the FSIS MLG 5.03 and 5A.00. The Canadian methods MFLP-80 and MFLP-30.

The FSIS methods can be found at the following site:

http://www.fsis.usda.gov/Science/Microbiological_Lab_Guidebook/index.asp

The Canadian methods can be found at the following site:

http://www.hc-sc.gc.ca/fn-an/res-rech/analy-meth/microbio/index_e.html

The samples must be analysed in a laboratory accredited by the Standards Council of Canada (SCC)and the required methods included in the laboratory scope of accreditation. (http://palcan.scc.ca/SpecsSearch/TLSearchForm.do). The operator must ensure that the laboratory performing the analysis is accredited by Standards Council of Canada and the methods used are in the scope of accreditation. A grace period has been given for the methods used to be accredited by SCC. The operator must therefore ensure that the methods used which are not yet in the scope of accreditation are included in the scope for the next SCC audit.

8. Laboratory results

The laboratory results must be sent simultaneously to both the operator and CFIA’s Food Microbiology and Chemical Evaluation unit in Ottawa. The operator must also advise the inspector in charge upon reception of the laboratory analysis.

Notification to CFIA should go to the following address:

Food Microbiology and Chemical Evaluation
Room 2025
159 Cleopatra Drive
Ottawa, (On), K1A 0Y9
or fax: (613) 221-7295
or e-mail: jchiasson@inspection.gc.ca

Please note that if, for whatever reason, the laboratory is unable to analyse and make an evaluation of the sample submitted for analysis, a replacement sample must be sent as soon as possible.

9. Follow-up on positive results

When pathogens are detected in a sample, the sampled lot is considered contaminated (adulterated) and following measures must be taken:

9.1.	The contaminated lot must remain under the operator’s control.
9.2.	An action plan must be submitted to CFIA covering the following points: action that will be taken on the unsatisfactory product to control the risk associated with the presence of pathogens in the product (e.g.: cooking schedule that will be applied to the unsatisfactory product to destroy Listeria monocytogenes) ascertain that no other product should be affected by the unsatisfactory result results of the investigation done to identify the cause of the deviation take appropriate corrective actions (including, if applicable, amending the HACCP plan) evaluate efficacy of the corrective actions (this must include additional final product testing) measures to prevent recurrences. the subsequent lots will be sampled and tested for the pathogen detected. For instance, if the pathogen detected was Listeria monocytogenes, the subsequent lots will be sampled and tested for Listeria monocytogenes or an indicator organism using a sampling method and frequency that provide a level of statistical confidence that ensures that each lot is not adulterated with Listeria monocytogenes before releasing into commerce the lots of product that may have been contaminated with Listeria monocytogenes. A hold and test regime will be put in place until the operator can demonstrate to the inspection staff that the Listeria problem has been addressed to CFIA’s satisfaction.
9.3.	The CFIA notification procedures must be clearly outlined in the written sampling program, e.g., who in the company will notify the V/IIC when the analysis is completed and the result is unsatisfactory, e.g., Listeria monocytogenes was detected in a sample.
9.4.	In an unlikely event that the sampled lot was distributed before the positive result was received or if it is determined that there are other products in distribution that are implicated by the positive result, the CFIA will notify FSIS (Food Safety and Inspection Service) immediately and provide the distribution details if the products have been exported to the USA. For RTE meat products zero tolerance applies for pathogens.

10. Record keeping

All laboratory reports should be kept for at least one year after the end of the sampled product’s shelf life.

Other records should be kept as per what is indicated in the operator’s HACCP plan.

Annex A

The following list must be used when two or more products are produced on the day of testing.

The highest risk post-lethality exposed RTE product produced at the time of collection must be sampled. The products are listed in decreasing order of risk (sliced deli-meats being the highest risk):

1. Deli-meats that are sliced in the federal registered establishment

2. Deli-meats shipped whole from the federal establishment (this does not include cook-in-bag products; only those exposed post-lethality)

3. Hotdog Products

4. Deli salads, pâtés, and meat spreads

5. Fully cooked type products (other than cooked products in 1-4 above)

6. Fermented products

7. Dried products

8. Salt-cured products

9. Products labelled as "Keep Frozen"

Annex B

The following general guideline should be followed for the sample collection and shipping procedure and maintenance of samples integrity:

1. Sample collection must be carried out on the RTE finished products that were post-lethality exposed.

2. Sample collection will be carried out by the individual designated in the establishment's written protocol who received the required training. Sampling supplies, such as sterile gloves, sterile sampling solutions, hand soap, sanitizing solution, etc., as well as specific materials needed for sampling will need to be assembled prior to beginning sample collection.

3. A sample, consisting of five sample units shall be drawn at random from each lot selected for sampling. Each sample unit shall consist of 150 g each or five intact units weighing at least total of 750 g. Do not sample the same lot for both Non-risk-based (M200 - managed by CFIA) and Risk-based (managed by industry) programs.

4. Unopened, original containers shall be sampled, when possible.

5. If the product is in bulk, several sample units can be collected from one container, while ensuring that the total number of sample units are not collected from one container. More than one sample unit may also be collected from large institutional or bulk containers when the total number of sample units required exceeds the number of containers in the lot. The collected sample units shall be placed in sterile containers. A sample unit will consist of more than one container when the lot consists of containers smaller than 150 g, e.g., six 25 g containers in each sample unit.

6. Aseptic techniques shall be employed in collecting the sample units.

7. The sample units must be kept refrigerated (0-4° C) or frozen at all time, depending on the nature of the product. The temperature of refrigerated samples must not exceed 7° C upon its arrival at the laboratory.

8. The establishments’ operators must have a written procedure explaining how they ensure that samples are protected from temperature abuse during sampling, storage and transportation to the laboratory, as well as from potential tempering.

9. Samples must be sent to a laboratory accredited to perform the analysis by the methods considered acceptable by the FSIS.

Glossary

Antimicrobial agent

A substance in or added to an RTE product that has the effect of reducing or eliminating a microorganism, including a pathogen such as Listeria monocytogenes, or that has the effect of suppressing or limiting growth of Listeria monocytogenes in the product throughout the shelf life of the product. Examples of antimicrobial agents added to RTE products are potassium/sodium lactate and sodium diacetate.

Antimicrobial process

An operation, such as freezing, applied to an RTE product that has the effect of suppressing or limiting the growth of a microorganism, such as Listeria monocytogenes, in the product throughout the shelf life of the product.

Deli product

A ready-to-eat meat or poultry product that typically is sliced, either in an official establishment or after distribution from an official establishment, and typically is assembled in a sandwich for consumption.

Hotdog product

A ready-to-eat meat or poultry frank, frankfurter, or wiener.

Lethality treatment

A process, including the application of an antimicrobial agent, that eliminates or reduces the number of pathogenic microorganisms on or in a product to make the product safe for human consumption. Examples of lethality treatment are cooking or the application of an antimicrobial agent or process that eliminates or reduces pathogenic microorganisms.

Lot definition

For the sampling purpose, a lot is defined as all products produced under the same conditions, using the same equipment and which are produced between two satisfactory complete sanitation operations. A sanitation operation is considered satisfactory if it cuts off the transfer of microbial contamination from one lot to another. The lot size should be the same as the one used by the operator in normal circumstances for commercial purposes. The operator cannot reduce the size of the lot in anticipation of testing requirements.

Post-lethality exposed product

Ready-to-eat product that comes into direct contact with a food contact surface after the lethality treatment in a post-lethality processing environment. (This excludes cook-in-bag products.)

Post-lethality processing environment

The area of an establishment into which product is routed after having been subjected to an initial lethality treatment . The product may be exposed to the environment in this area as a result of slicing, peeling, re-bagging, cooling semi-permeable encased product with a brine solution, or other procedures.

Post-lethality treatment

A lethality treatment that is applied or is effective after post-lethality exposure. It is applied to the final product or sealed package of product in order to reduce or eliminate the level of pathogens resulting from contamination from post-lethality exposure.

Ready-to-eat (As per the Meat Inspection Regulations)

Means, in respect of a meat product, a meat product that has been subjected to a process sufficient to inactivate vegetative pathogenic microorganisms or their toxins and control spores of food borne pathogenic bacteria so that the meat product does not require further preparation before consumption except washing, thawing or exposing the product to sufficient heat to warm the product without cooking it; (prêt à manger )

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